26/06/2026 Henlius’ serplulimab secures EU approval for sqNSCLC FDA accepts RP1 BLA resubmission for advanced Melanoma; Decision expected by August 2026 FDA grants tentative approval for enzalutamide tablets, adding new dosing strengths to compete with Xtandi Henlius’ serplulimab secures EU approval for sqNSCLC (Ref) The European Commission approved serplulimab (Hetronifly®; anti-PD-1) in combination with chemotherapy for first-line treatment of unresectable locally advanced

13/04/2026 FDA issues Complete Response Letter to Replimune’s RP1 BLA, halting accelerated approval path FDA Grants Priority Review for Ifinatamab Deruxtecan in ES-SCLC Daraxonrasib Demonstrates Unprecedented Survival Benefit in Phase 3 Pancreatic Cancer Trial Jaypirca (pirtobrutinib) combination significantly extended progression-free survival (PFS) in Relapsed/Refractory CLL/SLL SynOx Therapeutics' Phase 3 TANGENT Study Delivers Positive Results for TGCT Treatment IDEAYA an

18/09/2025 Replimune completed a Type A meeting with the FDA to discuss the CRL for vusolimogene oderparepvec + nivo ( Ref ) Replimune...

02/09/2025 Replimune has scheduled a Type A Meeting with the FDA for the CRL of RP1 + nivo in advanced melanoma ( Ref ) Replimune...

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA ( Ref ) The US FDA issued a Complete...